Q&A LoAs and co-registration

What should I prepare before buying a LoA?

• Gathering all information necessary to demonstrate the sameness with the substance used to build the Lead dossier (please use the SIP for that purpose - The Substance Identification Profile or SIP is available on the REC website, under each substance). You will need to check that the concentrations of main constituent/impurities are within the ranges proposed by the lead registrant. The analytical methods for concentration determination are suggested in the SIP itself.

• Gather information about your uses to check whether they are covered by the Lead dossier. If not, you will have to include them in your co-registration anyway.
• Make sure the company size of your company as currently indicated in your REACH IT account is up to date before submitting.
• Create a co-registration file using the IUCLID software, either by downloading the IUCLID software locally or by using IUCLID Cloud (https://echa.europa.eu/support/dossier-submission-tools/echa-cloud-services). Please refer to the ECHA website for more information.

What is the procedure to buy a LoA?

• Check the sameness of your substance with the SIP. You can start this procedure before buying the LoA.
• Contact us by email at rare-earth-consortium@arcadis.com with the following pieces of information:
o Name of the legal entity
o Contact name
o UUID
o Registration intention: Full/Intermediate
o Tonnage band
o Address (of the legal entity registering the substance)
o Invoicing address (if different)
o VAT number
o If we need to mention a P O Number (Purchase Order Number) on the LoA-invoice, please forward it to us.
• Arcadis will prepare a specific LoA Agreement for your substance/tonnage band/Legal Entity and will send it to your attention
• You sign the LoA Agreement and return it to Arcadis (a signed pdf is accepted)
• Arcadis issues the invoice related to the LoA
• After reception of the payment in full, Arcadis will send you the LoA package and token for you to complete your registration.

Can I review the LoA agreement and provide you with my comments before finalization and signature?
No. The Consortium is implementing the principle of fairness, transparency and non-discrimination. Therefore, the LoA Agreement cannot be modified, and the same template is used for all co-registrants. ARCADIS will provide you with a finalized version of the LoA agreement.

I am now producing/importing more tonnage of my substance and I need to update my tonnage band to a higher one. Should I buy another LoA?
In case you need to update your tonnage band to a higher one, contact us and we will generate an amendment to the current LoA agreement. You will be asked to pay the difference of price between the LoA-price of your current tonnage band and the one of the higher tonnage band. Please note that in case you produce/import less, you will not be refunded of the difference.

Do we need a paper version of the signed LoA Agreement?
Our policy is “let’s go digital”, i.e. we are happy with a signed pdf version. However, if you prefer an original signed version, inform us and we will make sure you receive a duly signed paper version. 

Do I have to pay a fee to ECHA on top of the LoA price?
Yes, you must pay a registration fee to ECHA. The fee depends on your tonnage band and the size of your company and other parameters.
After submission, ECHA will send you an invoice for the corresponding ECHA Fee (monitor closely your REACH-IT account).

Reference: COMMISSION IMPLEMENTING REGULATION (EU) 2015/864 of 4 June 2015 amending Regulation (EC) No 340/2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), OJ L139, 05.06.2015; p1.
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2015.139.01.0001.01.ENG

What is the content of the LoA package I will receive together with the token?
The LoA package will contain:
• The CSR for Annex VIII to  annex X dossiers
• The GoSu (Guidance on safe use) (for registration as an Annex VII and VIII under REACH)
• The name of the Joint Submission
• The token.
• The expiry date of the token
Please kindly note you will not receive the IUCLID file. Buying a LoA allows you to refer to the Lead dossier, but without ownership rights. Therefore, you don't receive the IUCLID dossier itself.

I receive a generic CSR with my LoA package. Do I have to modify or complete it?
In the provided CSR in the LoA package, both CSR part A and B are contained within the same document. This should be indicated when adding the document to the IUCLID file of your co-registration.
1. Adapt the CSR word-file as follows:
Before adding the CSR word document to your co-registration file, please first adapt the company specific sections marked in yellow. When doing this, you have the possibility to also adapt the identified uses within the CSR (should your company have other uses then those indicated in the Lead dossier). 
2. Please indicate under “Type of CSR” the option “own CSR initially prepared jointly within the consortium”
3. Please indicate under “CSR contains” all three options. For non-classified substances, sections 9 and 10 are included in the CSR but are empty.
4. Attach the finalized CSR word file under “Chemical Safety Report (CSR)”
Additional info on the CSR can be provided by your company in this record as well, however this is not an obligation. 
 
How to complete the sameness section of my co-registration dossier?
The co-registrant has the duty to complete this section by demonstrating that its substance is the same as the one used for building the Lead Dossier.  Please use the SIP (Substance Identification Profile) to do so. The SIP is available on the REC website under each substance section. Follow the ECHA guidance for more information.

My use(s) is/are not covered by the CSR included in the LoA package: what should I do?
Please use the CSR provided in the LoA package to adapt it accordingly by including you use(s).

Will it be possible to buy LoAs after May 2018?
Yes. First-time manufacturers and importers having registration duties can still buy a LoA after May 2018.

What should I do if the registration dossier is updated after I purchased a LoA and submitted my co-registration?
If some action from your side is required, you will be informed by a communication from the consortium. Please kindly note that not all updates of the dossier requires some changes in your co-registration file.

How is the reimbursement mechanism working?
When several companies are registering the same substance, a Joint Submission is created and LoAs are made available for sale to the SIEF participants. The price of the LoA is derived considering the tonnage bands and the number of co-registrants in the Joint Submission.
When the Joint submission is created, not all costs pertaining to the registration dossier are known. The initial number of co-registrants is also estimated. Therefore, the price of the LoA is derived in two different steps:
• The initial LoA prices: is based on the actual past costs, an estimation of the future costs and an initial estimation of the number of co-registrants, all per tonnage bands. This is the price you pay when buying a LoA.
• The final price of the LoA will be derived when all costs are known, when the actual number of co-registrants is known.  The final price is not expected to be derived before the end of the 12 years period of data protection under REACH.
If the final price of the LoA is lower than the initial price, each co-registrant is entitled to a reimbursement (depending of the tonnage band).
If the final price of the LoA is higher than the initial price, each co-registrant will have to pay an additional amount. Please note that the consortium has the right to invoice you an additional amount at any time after the purchase of the LoA should the expected future costs exceed the provisions embedded in the initial price of the LoA. 
Further details are provided in the LoA Agreement.

When can I expect a reimbursement?
The consortium will decide when to derive the final price of the LoAs, i.e. when all costs exposed for creating and maintaining the lead dossier and when the actual number of co-registrants are known and final.  This can take up to 12 years after submission of the data as first-time manufacturers or importers have still to buy a LoA after May 2018 till the end of the data protection period under REACH.  The LoA-purchasers will be informed through a communication from the consortium. Please kindly note it is not foreseen to proceed with intermediate reimbursement.

Can I join the REC Consortium?
Please note that the Rare Earth Consortium does not consider any further application for membership for the time being.
The consortium was originally formed in order to gather potential registrants of rare earth compounds and discuss the testing strategy and cost sharing between the different actors in the dossier preparation. The consortium agreement foresees a clause indicating that no membership application will be handled in the six-month period prior to a Reach deadline (and we are currently in this six-month period) because the members want to devote all their attention on the dossiers to be submitted against the REACH deadline. 
Please kindly note you don't have to become member of the consortium for buying a letter of access to the substances registered by the members of the consortium. We will therefore ask you to buy a LoA for your substances of interest.